About the Company:
Family owned since 1908 Merz Aesthetics is the world’s largest dedicated medical aesthetics business. Choose Merz Aesthetics because it is unique - unique in our relationships with customers, in our products and in the way we treat each other.
As Associate Director/ Director, Quality Engineering, you are accountable for the Development, Execution and Delivery of domestic and international Quality Strategies for Energy Based Devices at Merz Aesthetics. You will partner with with R&D, Operations, Engineering, Clinical & Marketing to assure all Quality Objectives are Identified and Fulfilled, Drive Continuous Improvement and Motivate and Lead your Team to Achieve Business Objectives.
Key Responsibilities:
Associate Director:
Lead Quality Support for Design Control:
- Lead quality team in supporting operations, sustaining engineering, R&D and NPI departments in the development, verification and validation of product changes and introduction of new products and process.
- Monitor quality metrics to identify systemic product and process issues assuring appropriate investigation, correction, and corrective and preventive action when needed. Partners with R&D, Operations, Clinical & Marketing to assure there is appropriate execution of design controls and process validation.
Lead Risk Management:
- Lead Risk Management activities including review and coordination of quality activities to risk.
Lead Supplier Quality and Received Goods Inspection:
- Oversee and manage the Supplier Quality Management System to include oversight of suppliers that manufacture and supply products and services to Merz (including: Biologics, Rx, OTC, Medical Devices (510K, PMA), Cosmetics and Nutritional Supplements.
- Oversee and manger the team performing received goods inspections ensuring appropriate inspection methods are established and ensure timely and compliant inspections are completed.
Support NCR and CAPA:
- Support corrective/preventive actions and product non-conformance including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
Quality initiatives:
- Identifies and implements new quality improvement initiatives/ projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies.
- Works with manufacturing and other functional groups on manufacturing regulatory compliance issue.
Adherence to Regulations:
- Ensure compliance of the Quality Management System. Operate to the most current version of ISO 13485 and 21CFR Part 820 FDA regulations, MDD/MDR, and Canadian Medical Device Regulations (CMDR), etc. Interface with external agencies as required including the FDA and the Notified Body.
Director:
Energy Based Device Quality Leader: Operate as primary Quality leader for Merz Energy Based Devices. Act as liaison between Global Merz sites and functions.
Product Quality: Develop, conduct, control and monitor processes to ensure that product conforms to its specifications. This includes but is not limited to:
- Incoming materials meet required specifications.
- In-process monitoring during manufacturing.
- Final release testing using representative samples.
- Control if material/product and status
- Non-Conforming product is appropriately controlled, including the authority for the final disposition of non-conforming product.
- Establish and maintain corrective & preventive action procedures.
- Change control.
- Environmental & Contamination Control of Manufacturing.
- Personnel are appropriately qualified and trained.
- Buildings & facilities are suitable in design and space.
- Product is appropriately handled, stored, and distributed to ensure mix-ups, damage, deterioration, contamination, or other adverse effects to product do not occur.
- Equipment is appropriately designed, validated, and maintained.
- Internal audits of manufacturing are completed by the Compliance function.
- Compliance with standards, internal procedures, etc.
- Maintenance of records to demonstrate control of the Quality System as outline above.
- Documented Instructions (appropriate SOPs, DHR, etc.).
State of the Art: Evaluate and Implement New Technologies per Quality System Standards, Quality System Regulations, and Identify new quality improvement initiatives / projects in accordance with cGMP Expectations to Improve Compliance, Quality Levels (reducing defects), and Improve Operational Efficiencies.
Quality Metrics and Design Control: Monitor quality metrics to identify systemic product and process issues assuring appropriate investigation, correction, and corrective and preventive action when needed. Partners with R&D, Operations, Clinical & Marketing to assure there is appropriate execution of design controls and process validation.
Adherence to Regulations: Ensure compliance of the Quality Management System as it pertains to Energy Based Devices. Operate to the most current version of ISO 13485 and 21CFR Part 820 FDA regulations, MDD/MDR, and Canadian Medical Device Regulations (CMDR), etc. Interface with external agencies as required including the FDA and the Notified Body.
Product Development and Change Control: Collaborate with R&D and Sustaining Engineering regarding quality assurance of new products designed and manufactured products on market to rectify problems.
Personnel Management: Supervise and provide direction to assigned staff in carrying out their work.
Global Alignment: Provide strategic and tactical support to Global Quality initiatives.
Organizational Support: Provide strategic and tactical support to Global Quality initiatives.
Budget: Manage Departmental Budgets in accordance with approved targets.
Knowledge, skills and abilities (incl. languages):
- Excellent written and oral communication skills with attention to detail. Required
- Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines. Required
- Ability to host, facilitate and execute audits with internal and external audiences. Required
- Knowledge and understanding of US and ex-US regulations and ICH guidelines. Required
- Highly computer literate (Word, Excel PowerPoint), including formatting and getting documents submission ready. Required
Knowledge of methods:
- Lean / Six Sigma Green Belt. Preferred
- ASQ CQA, CQE, CQMOE. Preferred
Personal skills:
- Ability to work effectively in a global, matrix environment. Required
- Ability to work independently as well as direct and control the efforts of Direct Reports as applicable. Required
- Strong interpersonal skills and ability to collaborate effectively with various technical area experts. Required
Experience:
Associate Director:
• 8 years minimum in the medical products industry required
• 5 years minimum in a Quality function preferred
Director:
- 8 years minimum in the medical products industry required, with direct experience with Energy Based Medical Devices. Required
- 5 years minimum in a Quality function. Required
- 3 years minimum in a Quality Operations role. Required
Education:
- Bachelor’s Degree in a Physical Science or Equivalent. Required
- Master’s degree in physical science or Business. Preferred
Benefits:
- Comprehensive Medical, Dental, and Vision plans.
- 20 days of Paid Time Off.
- 15 paid holidays.
- Paid Sick Leave.
- Paid Parental Leave.
- 401(k).
- Employee bonuses.
- And more!
Your benefits and PTO start the date you're hired with no waiting period! Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!
Racine, Wisconsin
Full Time, Contractor